Breast Neoplasms
Conditions
Keywords
Breast Neoplasms, Oxaliplatin, S1
Brief summary
Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and taxane
Detailed description
The main purpose of this study is to find out the efficacy and safety profile of TS-1 with oxaliplatin in previously anthracycline and taxane pretreated patients.
Interventions
DRUGTS-1 and Eloxatin
S-1 80 mg/m2/day on day 1-14 Oxaliplatin 130 mg/m2 IV for 2 hour on day 1 Every 3 week Number of Cycles: until progression or unacceptable toxicity
Sponsors
Korean Cancer Study Group
National Cancer Center, Korea
Seoul National University Bundang Hospital
Samsung Medical Center
Asan Medical Center
Severance Hospital
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* M/F age ≥ 18 * Metastatic(TxNxM1) or inoperable locally recurrent breast cancer(rT4NxM0) after taxane & anthracycline therapy * Measurable disease (RECIST) : A patient with at least one measurable lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT * No prior treatment with S-1, capecitabine, platinum In metastatic setting * Must have received an anthracycline and taxane in adj. or metastatic settings (concurrent, sequential, or combined with other drugs) * For taxanes (Paclitaxel (P) / Docetaxel (D)) 1. Must have progressed while or after receiving P or D (Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease) 2. Only 1 adjuvant regimen permitted (neoadjuvant immediately followed by surgery and immediately followed by adj. is permitted) * For anthracyclines 1. Progressed while on anthracycline treatment, with or without initial response or 2. Have received an adequate course of anthracyclines defined as follows: <!-- --> 1. Adj.: Must have received a standard regimen (doxorubicin ≥ 240 mg/m2 or ≥ 360 mg/m2 epirubicin or equivalent) 2. Metastatic: Must have received a standard regimen(doxorubicin ≥300mg/m2 or equivalent) * Not candidate for Herceptin * ECOG PS ≤ 2 * Completion of all prior chemotherapy ≥ 3 wks prior to enrol * Completion of hormonal therapy 2 wks prior to enroll * Resolution of all clinically significant toxic effects (excluding alopecia and sensory neuropathies) of any prior surgery or therapy to grade ≤ 1 (NCI CTCAE 3.0), for peripheral neuropathy grade ≤ 2 (NCI CTCAE 3.0), or to within the limits listed in the specific inclusion/
Exclusion criteria
* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it. * Informed consent obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | TTP, OS |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the time to progression - To determine the response duration - To determine the overall survival - To determine toxicities - To determine the pharmacogenomic predictor (association study) | PFS, OS |
Countries
South Korea
Outcome results
None listed